Implantable or insertable medical devices for controlled delivery of a therapeutic agent
First Claim
1. A therapeutic-agent-releasing medical device comprising:
- (a) an implantable or insertable medical device;
(b) a release layer disposed over at least a portion of the implantable or insertable medical device, said release layer comprising (i) a first polymer comprising one or more polymer chains that form one or more polymer phase domains when the first polymer is in a pure solid-state form; and
(ii) a second polymer comprising two or more polymer chains that form two or more phase domains when the second polymer is in a pure solid-state form, wherein at least one polymer chain in the second polymer is compatible with at least one polymer chain in the first polymer; and
(c) a therapeutic agent, wherein said release layer regulates the rate of release of the therapeutic agent from the medical device upon implantation or insertion of the device into a patient.
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Accused Products
Abstract
The present invention is directed to novel implantable or insertable medical devices that provide release of a therapeutic agent. According to a first aspect of the present invention, a therapeutic-agent-releasing medical device is provided, which comprises: (a) an implantable or insertable medical device; (b) a release layer disposed over at least a portion of the implantable or insertable medical device, and (c) a therapeutic agent. The release layer regulates the rate of release of the therapeutic agent from the medical device upon implantation or insertion of the device into a patient. The release layer comprises (i) a first polymer comprising one or more polymer chains that form one or more polymer phase domains when the first polymer is in a pure solid-state form; and (ii) a second polymer comprising two or more polymer chains that form two or more phase domains when the second polymer is in a pure solid-state form. The first and second polymers are preferably selected such that at least one polymer chain in the second polymer is compatible with at least one polymer chain in the first polymer. The present invention is also directed to methods of forming the above implantable or insertable medical devices, methods of administering a therapeutic agent to a patient using such devices, and methods of modulating the release of therapeutic agents from implantable or insertable medical devices.
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Citations
32 Claims
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1. A therapeutic-agent-releasing medical device comprising:
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(a) an implantable or insertable medical device;
(b) a release layer disposed over at least a portion of the implantable or insertable medical device, said release layer comprising (i) a first polymer comprising one or more polymer chains that form one or more polymer phase domains when the first polymer is in a pure solid-state form; and
(ii) a second polymer comprising two or more polymer chains that form two or more phase domains when the second polymer is in a pure solid-state form, wherein at least one polymer chain in the second polymer is compatible with at least one polymer chain in the first polymer; and
(c) a therapeutic agent, wherein said release layer regulates the rate of release of the therapeutic agent from the medical device upon implantation or insertion of the device into a patient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 25, 26, 27, 28, 29, 30, 31, 32)
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16. A method of modulating the release rate of a therapeutic agent from a medical device comprising:
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providing a medical device comprising;
(a) an implantable or insertable medical device;
(b) a release layer disposed over at least a portion of the implantable or insertable medical device, said release layer comprising a first polymer which comprises one or more polymer chains that form one or more polymer phase domains when said first polymer is in a pure solid-state form, and (c) a therapeutic agent, said release layer regulating the rate of release of the therapeutic agent from the medical device upon implantation or insertion of the device into a patient; and
modulating the release rate from said medical device by adding to said release layer a second polymer which comprises two or more polymer chains that form two or more phase domains when said second polymer is in a pure solid-state form, wherein at least one polymer chain in said second polymer is compatible with at least one polymer chain in said first polymer. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24)
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Specification